FDA 510(k)
Substantially Equivalent for Some Indications
🇺🇸 United States
SP 4
K Number: K853541
·
Decision Mar 28, 1986
Classifications
0
FEI Numbers
0
Registration Numbers
0
Same Product Code
0
Applicant Total
21
Review Days
214
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Basic Information
- Device Name
- SP 4
- K Number
- K853541
- Clearance Type
- Traditional
- Decision
- Substantially Equivalent for Some Indications
- Applicant
- Robert Bosch Corp.
- Date Received
- August 26, 1985
- Decision Date
- March 28, 1986
- Advisory Committee
- Unknown
- Review Advisory Committee
- PM
- Third Party
- N
Other Clearances by Robert Bosch Corp.
| K Number | Device Name | ||
|---|---|---|---|
| K854493 | ERG 555 COUCH ERGOMETER | Jun 16, 1986 | Substantially Equivalent |
| K854491 | ERG 550 ERGOMETER BICYCLE | Jun 16, 1986 | Substantially Equivalent |
| K854492 | ERG 551 ERGOMETER, BICYCLE | Jun 16, 1986 | Substantially Equivalent |
| K853154 | HV-4 | Mar 28, 1986 | Substantially Equivalent for Some Indications |
| K853271 | HEARING AID ANALYSIS SYSTEM | Jan 16, 1986 | Substantially Equivalent |
| K851485 | DEFI 502 | Aug 29, 1985 | Substantially Equivalent |
| K840717 | ECS 502 | Aug 19, 1985 | Substantially Equivalent |
| K851937 | SONOMED 4 | Jul 17, 1985 | Substantially Equivalent |
| K850188 | BOSCH IN THE EAR HEARING AID SUPERSTAR | Apr 9, 1985 | Substantially Equivalent |
| K850186 | POST AURICULAR HEARING AIDS STAR 33PP, 44,55F & | Mar 27, 1985 | Substantially Equivalent |